NCT05067374

Brief Summary

In France, a breast cancer screening is organized since 2004 for women aged 50-74. On the other hand, even though the seroprevalence of hepatitis C in the general French population is less than 1%, it is estimated that more than 75,000 people live with the virus without knowing it. To answer the WHO objective of eliminating hepatitis C by 2030 and in France by 2025, the investigators need to organize targeted screening. Women aged more than 50 years old, by their possible antecedents in life, are an exposed population. The investigators propose to pair the already organized breast cancer screening with a hepatitis-screening test by rapid diagnostic orientation test (TROD) and evaluate the adherence of women in this paired screening. For women with positive TROD, a specialized care will be organized.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 5, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2025

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

September 23, 2021

Last Update Submit

March 30, 2022

Conditions

Hepatitis CBreast Cancer

Keywords

Rapid orientation diagnostic testHepatitis CBreast cancerMammographyBlood samplePaired screening

Outcome Measures

Primary Outcomes (1)

  • Adherence to the hepatitis C screening

    Description: Number of women who have agreed to do the hepatitis C screening by rapid orientation diagnostic test (TROD) among the woman to whom it was offered.

    At inclusion

Secondary Outcomes (12)

  • Percentage of positive hepatitis C TROD

    At inclusion

  • Percentage of positive hepatitis C RNA

    at 1 year after inclusion day

  • Retrospective care cascade : percentage of women with knowledge of their positive serological status

    At inclusion day

  • Retrospective care cascade : percentage of women with a HCV viral load done

    At inclusion day

  • Retrospective care cascade : percentage of treated women

    At inclusion day

  • +7 more secondary outcomes

Eligibility Criteria

Age50 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women participating in the organized systematic breast cancer screening

You may qualify if:

  • \- Women aged 50-74 inclusive
  • Doing a breast cancer screening
  • Able to understand and complete a questionnaire on their own or with the help of a third party
  • Able to understand the study and follow the protocol
  • Having signed the consent form
  • With social security plan

You may not qualify if:

  • \- Cannot sign the consent or follow the protocol
  • Under French legal protection measure (sauvegarde de justice, tutelle or curatelle)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beausoleil private clinic

Montpellier, Occitanie, 34000, France

NOT YET RECRUITING

Lapeyronie radiology ward (Montpellier University hospital)

Montpellier, Occitanie, 34000, France

RECRUITING

Le Millénaire private clinic

Montpellier, Occitanie, 34000, France

RECRUITING

Victor Hugo Center

Montpellier, Occitanie, 34000, France

RECRUITING

MeSH Terms

Conditions

Hepatitis CBreast Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hélène DONNADIEU RIGOLE, Pr

    Biochemistry department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene DONNADIEU RIGOLE, MH PD

CONTACT

04 67 33 70 20h-donnadieu_rigole@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 5, 2021

Study Start

March 23, 2022

Primary Completion

March 23, 2024

Study Completion

March 23, 2025

Last Updated

April 8, 2022

Record last verified: 2022-03

Locations

FR(4)